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With the North American Spine Society (NASS) Annual Meeting just weeks away, we’re sure to hear plenty of talk about technology, innovation and the future of spine surgery. One barometer of novel products is FDA’s Breakthrough Devices Program.
The program is a voluntary process for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to provide patients and surgeons with timely access to medical devices by speeding development, assessment and market review. Carlsmed’s aprevo, patient-specific interbody fusion devices, and Premia Spine’s TOPS System, a total facet joint replacement implant, are examples of Breakthrough Devices that have reached the market in recent years.
As we turn toward the NASS meeting, it’s a good time to recap spine-related implants and biologics that were granted this designation in 2024.
Bioretec RemeOs Spinal Interbody Cage
RemeOs biodegradable cages are intended to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
RemeOs absorbs into bone, assisting in the healing process. The same surgical techniques can be used for RemeOs products as for conventional metal implants.
Canary Medical Canturio Lumbar Cartridge (canturio lc)
The canturio lc device is intended for use with a lumbar interbody system for spinal fusion from L1-S1 and is accompanied by the Canary Health Implanted Reporting Processor (CHIRP) System.
canturio lc is intended to collect various kinematic measures for at least 10 years and pool the data from each of the multiple parameters across the patient population. Canary’s platform will provide clinicians with frequent, objective aggregate population data for each patient’s activity levels and kinematics to rank each patient’s performance versus their peers based on age group, gender and time since surgery. Clinicians will be able to access and use this functional information to help determine whether to augment their in-office patient examinations and/or to update their patient’s care plan in the year following surgery.
Medtronic Infuse Bone Graft
This designation pertains to the use of Infuse bone graft in a transforaminal lumbar interbody fusion (TLIF) surgical approach at one or two adjacent levels from L2 – S1. In spine surgery, Infuse is used with select Medtronic interbody fusion devices to treat degenerative disc disease.
Medtronic is enrolling patients in a prospective, randomized clinical trial to collect evidence to demonstrate that the application is safe and effective for the TLIF indication.
MiRus EUROPA Posterior Cervical System
This device is based on MiRus’ proprietary rhenium alloy and is designed to treat the cervical and upper thoracic spine.
EUROPA PCF is built around a 2.9 mm MoRe rod, which is much smaller than current commercial systems. The rod allows low-profile pedicle screw tulips, leading to less invasive surgery and less hardware prominence in smaller patients. Although lower diameter, MoRe rods provide a high level of rigidity, strength and fatigue resistance, which can reduce the risk of spine rod fractures.
OrthoPediatrics eLLi Growing Rod
eLLi is designed to address severe pathology associated with Early Onset Scoliosis (EOS), which can be associated with thoracic insufficiency. eLLi aims to offer a non-invasive means of extending the growing rods that provides increased force, enhanced mechanical reliability and superior distraction precision, while also addressing safety concerns associated with current technology.
ORTHOSON Bio-Structural Gel
This micro-invasive treatment is designed to alleviate back pain due to degenerative disc disease. ORTHOSON’s Bio-Structural Gel follows the natural fissures of degeneration in the nucleus pulposus of the intervertebral disc before gelling in situ to form a highly hydrated biology-supporting structure. The patented pNIPAM-DMAc co-polymer is designed to mimic the body’s own natural tissue in the nucleus pulposus, while restoring mechanical function of the intervertebral disc.
Renovos Biologics RENOVITE BMP-2
RENOVITE Bone Morphogenic Protein 2, based on a proprietary synthetic nanoclay gel, is in development as an alternative to currently available bone graft materials. The injectable gel allows localized bone formation at the target site. It contains BMP-2, a growth factor that promotes in-growth of bone-forming cells. The nanoclay gel does not leach BMP-2, and the gel biodegrades as new bone forms.
RENOVITE BMP-2 gel has applications in spinal fusion, bone defects and ankle surgery.
SI-BONE iFuse TORQ TNT Implant System
iFuse TORQ TNT is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next-generation technology for pelvic fragility fracture fixation and sacroiliac joint fusion.
TNT includes a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum and into the contralateral ilium (“through and through,” thus TNT). TNT is designed to improve early fixation and reduce the rate of screw backout, which may allow for early patient weight-bearing and mobilization.
With the North American Spine Society (NASS) Annual Meeting just weeks away, we’re sure to hear plenty of talk about technology, innovation and the future of spine surgery. One barometer of novel products is FDA’s Breakthrough Devices Program.
The program is a voluntary process for certain medical devices that provide for more effective...
With the North American Spine Society (NASS) Annual Meeting just weeks away, we’re sure to hear plenty of talk about technology, innovation and the future of spine surgery. One barometer of novel products is FDA’s Breakthrough Devices Program.
The program is a voluntary process for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to provide patients and surgeons with timely access to medical devices by speeding development, assessment and market review. Carlsmed’s aprevo, patient-specific interbody fusion devices, and Premia Spine’s TOPS System, a total facet joint replacement implant, are examples of Breakthrough Devices that have reached the market in recent years.
As we turn toward the NASS meeting, it’s a good time to recap spine-related implants and biologics that were granted this designation in 2024.
Bioretec RemeOs Spinal Interbody Cage
RemeOs biodegradable cages are intended to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine.
RemeOs absorbs into bone, assisting in the healing process. The same surgical techniques can be used for RemeOs products as for conventional metal implants.
Canary Medical Canturio Lumbar Cartridge (canturio lc)
The canturio lc device is intended for use with a lumbar interbody system for spinal fusion from L1-S1 and is accompanied by the Canary Health Implanted Reporting Processor (CHIRP) System.
canturio lc is intended to collect various kinematic measures for at least 10 years and pool the data from each of the multiple parameters across the patient population. Canary’s platform will provide clinicians with frequent, objective aggregate population data for each patient’s activity levels and kinematics to rank each patient’s performance versus their peers based on age group, gender and time since surgery. Clinicians will be able to access and use this functional information to help determine whether to augment their in-office patient examinations and/or to update their patient’s care plan in the year following surgery.
Medtronic Infuse Bone Graft
This designation pertains to the use of Infuse bone graft in a transforaminal lumbar interbody fusion (TLIF) surgical approach at one or two adjacent levels from L2 – S1. In spine surgery, Infuse is used with select Medtronic interbody fusion devices to treat degenerative disc disease.
Medtronic is enrolling patients in a prospective, randomized clinical trial to collect evidence to demonstrate that the application is safe and effective for the TLIF indication.
MiRus EUROPA Posterior Cervical System
This device is based on MiRus’ proprietary rhenium alloy and is designed to treat the cervical and upper thoracic spine.
EUROPA PCF is built around a 2.9 mm MoRe rod, which is much smaller than current commercial systems. The rod allows low-profile pedicle screw tulips, leading to less invasive surgery and less hardware prominence in smaller patients. Although lower diameter, MoRe rods provide a high level of rigidity, strength and fatigue resistance, which can reduce the risk of spine rod fractures.
OrthoPediatrics eLLi Growing Rod
eLLi is designed to address severe pathology associated with Early Onset Scoliosis (EOS), which can be associated with thoracic insufficiency. eLLi aims to offer a non-invasive means of extending the growing rods that provides increased force, enhanced mechanical reliability and superior distraction precision, while also addressing safety concerns associated with current technology.
ORTHOSON Bio-Structural Gel
This micro-invasive treatment is designed to alleviate back pain due to degenerative disc disease. ORTHOSON’s Bio-Structural Gel follows the natural fissures of degeneration in the nucleus pulposus of the intervertebral disc before gelling in situ to form a highly hydrated biology-supporting structure. The patented pNIPAM-DMAc co-polymer is designed to mimic the body’s own natural tissue in the nucleus pulposus, while restoring mechanical function of the intervertebral disc.
Renovos Biologics RENOVITE BMP-2
RENOVITE Bone Morphogenic Protein 2, based on a proprietary synthetic nanoclay gel, is in development as an alternative to currently available bone graft materials. The injectable gel allows localized bone formation at the target site. It contains BMP-2, a growth factor that promotes in-growth of bone-forming cells. The nanoclay gel does not leach BMP-2, and the gel biodegrades as new bone forms.
RENOVITE BMP-2 gel has applications in spinal fusion, bone defects and ankle surgery.
SI-BONE iFuse TORQ TNT Implant System
iFuse TORQ TNT is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next-generation technology for pelvic fragility fracture fixation and sacroiliac joint fusion.
TNT includes a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum and into the contralateral ilium (“through and through,” thus TNT). TNT is designed to improve early fixation and reduce the rate of screw backout, which may allow for early patient weight-bearing and mobilization.
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
